Ibandronate Sodium Injection (Ibandronate Sodium Monohydrate)

Adult administration

Administer 3mg by intravenous injection once every 3 months for 15 - 30 seconds. Patients should also intake calcium and vitamin D as a supplement. If a dose is missed on the scheduled treatment day, it should be administered as soon as possible, and thereafter, regular dosing should continue at 3-month intervals.

Child administration

Efficacy and safety in children under 18 have not been studied.

This medication must be administered intravenously, and caution is required as administration into arteries or perivascular injection can cause damage to surrounding tissues. It should not be used in patients with an allergy to this drug or its ingredients, or in untreated hypocalcemia. During treatment, gastrointestinal side effects such as gastritis, diarrhea, abdominal pain, dyspepsia, nausea, and constipation may occur. Musculoskeletal side effects such as myalgia, arthralgia, and musculoskeletal pain may also arise. Some patients may experience systemic and skin adverse reactions such as flu-like symptoms, fatigue, headache, and rash. This drug can temporarily lower serum calcium levels; therefore, it is necessary to treat metabolic disorders like hypocalcemia before administration and ensure adequate intake of calcium and vitamin D. Patients undergoing dental treatment or with poor oral hygiene are at risk of osteonecrosis of the jaw and should have a dental examination prior to administration. During treatment, excessive dental procedures should be avoided, and if symptoms of osteonecrosis of the jaw appear, medical consultation should be sought immediately. Serious allergic reactions such as external auditory canal osteonecrosis, ocular inflammation, and anaphylaxis have also been reported; immediate medical attention is required if symptoms occur. Long-term use may result in atypical fractures in the femur and other bones, so patients should inform healthcare professionals of any pain in the thigh or groin. This drug has not been confirmed safe for use in pregnant or breastfeeding women, so its use is not recommended. No dosage adjustment is needed for the elderly, but safety and efficacy in children under 18 have not been established. Overdose may affect the kidneys and liver, so renal and hepatic functions should be monitored regularly, and appropriate treatment should be received if necessary. This medication should not be mixed with calcium-containing solutions and must be administered exclusively by intravenous injection. After use, the injection needle and syringe should not be reused and should be disposed of safely.

Serious side effects

Urticaria, severe swelling (angioedema, facial swelling/edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, abnormal respiratory symptoms accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme fatigue throughout the body, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances.

Mild side effects

• Gastritis
• diarrhea
• abdominal pain
• dyspepsia
• nausea
• constipation
• musculoskeletal pain
• arthralgia
• myalgia
• flu-like symptoms

This medication should be stored in a sealed container to prevent exposure to air and moisture, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will help ensure the drug's efficacy is maintained safely.

Appearance

A colorless, transparent solution contained in a colorless, transparent glass prefilled syringe, with an attached single-use injection needle.

Package unit

3mL x 1 vial